Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation

Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Triumf

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triumf; Subjects who have cataract surgery with Triumf IOL	Device: Triumf; Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected near visual acuity	Visual acuity at near with bare eyes	3 months
Uncorrected distant visual acuity	Visual acuity at distant with bare eyes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	Ability to recognize figure or letter at different contrast environment	3 months
Quality of Vision	Degree of various symptoms associated with vision	3 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Tae-Young Chung, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Depth and focus
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 2019-12-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No